Comparison of Intrathecal Versus Epidural Fentanyl on Fetal Bradycardia in Labor Combined Spinal Epidural Analgesia

NCT ID: NCT03623256

Last Updated: 2021-07-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 558 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-28
• Study Completion Date: 2023-10-31

Brief Summary

There have been studies reporting that combined spinal-epidural (CSE) with fentanyl and bupivacaine produce fetal bradycardia, (M.Kuczkowski, 2004) (Abrão K, 2009 ). It is unknown whether any differences in risk exist between fentanyl and bupivacaine when used as a part of the CSE procedure. Some authors have reported cases of parturients who developed uterine hyperactivity and fetal bradycardia after subarachnoid administration of fentanyl during labor. (D'Angelo & Eisenach, 1997) (Friedlander JD, 1997). It has been suggested that uterine hypertonus, leading to non-reassuring fetal heart rate tracings, might be an etiologic factor in these situations. (Landau, 2002).

We propose this study to test the hypothesis that administration of epidural fentanyl is associated with a lower incidence of fetal bradycardia compared to intrathecal fentanyl.

Detailed Description

After approval by the Institutional Review Board and written informed consent, we plan to prospectively study pregnant patients who undergo neuraxial labor analgesia. All patients will receive combined-spinal-epidural analgesia. Patients will be randomly assigned to one of four groups by means of sealed envelope technique. Group A will receive a spinal dose of preservative-free fentanyl 25 mcg. Group B will receive one dose of spinal preservative-free 0.25% bupivacaine. Group C will receive a spinal combination of preservative-free 0.25% bupivacaine and fentanyl 25 mcg. Group D will receive spinal preservative-free 0.25% bupivacaine and epidural fentanyl 100 mcg. After the procedure, we will monitor the fetal heart rate and tocometry tracings for 20 min. Thereafter, an epidural infusion with a solution containing 0.125% bupivacaine and 2mcg/mL of fentanyl will be started. We will record demographic variables (age, and BMI), obstetric variables (parity, gestational age, cervical dilation, oxytocin infusion) and anesthetic variables (level of insertion of epidural catheter).

Primary outcomes:

Fetal heart rate (baseline, minimal and abnormal patterns)

Secondary outcomes:

• Blood pressure (systolic, diastolic and mean) measured at baseline and every 5 minutes after administration of medication.
• Dermatomal level measured after 20 minutes of medication administration.
• Pain level (visual analogue scale) after 20 minutes of medication administration.
• Patient satisfaction level (1-10 scale) after 20 minutes of medication administration.
• Uterine tone measured with tocometer at baseline and during 20 minutes after medication administration.

Conditions

Labor Pain; Obstetric Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Spinal Fentanyl

Spinal dose of preservative-free fentanyl 25 mcg (Volume 0.5 mL)

Group Type: ACTIVE_COMPARATOR

Spinal fentanyl

Intervention Type: DRUG

25 mcg of fentanyl (0.5 mL) will be administered by intrathecal route.

Spinal Bupivacaine

Spinal dose of preservative-free 0.25% bupivacaine (Volume 0.5 mL)

Group Type: ACTIVE_COMPARATOR

Spinal bupivacaine

Intervention Type: DRUG

1.25 mg of preservative-free bupivacaine 0.25% (0.5 mL) will be administered by intrathecal route.

Spinal Fentanyl and Bupivacaine

Spinal combination of preservative-free 0.25% bupivacaine (0.5 mL) and fentanyl 25 mcg (0.5 mL). (Total Volume 1 mL).

Group Type: ACTIVE_COMPARATOR

Spinal Fentanyl and Bupivacaine

Intervention Type: DRUG

1.25 mg of preservative-free bupivacaine 0.25% (0.5 mL), and 25 mcg of fentanyl (0.5 mL) will be administered by intrathecal route.

Epidural fentanyl /spinal bupivacaine

Spinal preservative-free 0.25% bupivacaine (Volume 0.5 mL) and epidural fentanyl 100 mcg (Volume 2 mL).

Group Type: EXPERIMENTAL

Epidural fentanyl /spinal bupivacaine

Intervention Type: DRUG

1.25 mg of preservative-free bupivacaine 0.25% (0.5 mL) will be administered by intrathecal route, and 100 mcg of fentanyl (2 mL) will be administered by epidural route.

Interventions

Spinal fentanyl

25 mcg of fentanyl (0.5 mL) will be administered by intrathecal route.

Intervention Type: DRUG

Spinal bupivacaine

1.25 mg of preservative-free bupivacaine 0.25% (0.5 mL) will be administered by intrathecal route.

Intervention Type: DRUG

Spinal Fentanyl and Bupivacaine

1.25 mg of preservative-free bupivacaine 0.25% (0.5 mL), and 25 mcg of fentanyl (0.5 mL) will be administered by intrathecal route.

Intervention Type: DRUG

Epidural fentanyl /spinal bupivacaine

1.25 mg of preservative-free bupivacaine 0.25% (0.5 mL) will be administered by intrathecal route, and 100 mcg of fentanyl (2 mL) will be administered by epidural route.

Intervention Type: DRUG

Other Intervention Names

Fentora; Marcaine; Marcaine and Fentora; Marcaine and Fentora

Eligibility Criteria

Inclusion Criteria

• Older than 18 years
• Term pregnancy (> 37 weeks)
• Absence of obstetric morbidities
• Active labor
• Request of neuraxial analgesia per patient and/or obstetrician
• Combined spinal-epidural technique

Exclusion Criteria

• Abnormal fetal heart rate tracing.
• Uterine tachysystole before neuraxial analgesia.
• Baseline blood pressure <90/60 mmHg.
• Allergies to local anesthetics or fentanyl.
• Maternal fever.
• Pruritus before performance of neuraxial analgesia.
• Contraindications for neuraxial technique.
• Unwillingness to participate.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Augusta University

OTHER

Sponsor Role: lead

Responsible Party

Efrain Riveros Perez, MD

Assistant Professor Department of Anesthesiology and Perioperative Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Efrain Riveros Perez, MD

Role: PRINCIPAL_INVESTIGATOR

Augusta University

Locations

Augusta University

Augusta, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Efrain Riveros Perez, MD

Role: CONTACT

eriverosperez@augusta.edu

7067217361

Alexander R Rocuts Martinez, MD

Role: CONTACT

krocutsmartinez@augusta.edu

3304074681

Facility Contacts

Steffen Meiler, MD

Role: primary

smeiler@augusta.edu

706-721-3671

Other Identifiers

1238162

Identifier Type: -

Identifier Source: org_study_id